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1,239 stories matching this filter · ← front page

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  • Forbion raises $2.6 billion for two European biotech venture funds
    Forbion announced it has secured 2.3 billion euros ($2.6 billion) across two new venture funds, its largest raise to date. The funds, called Forbion Growth Opportunities IV and Forbion Ventures Fu…
    BioPharma Dive · 14d agoDealPositive↗ source
  • ArriVent shares tumble as lung cancer trial of furmonertinib misses primary goal
    ArriVent BioPharma reported that its late-stage study of furmonertinib in patients with EGFR exon 20 insertion-mutated non-small cell lung cancer did not achieve its primary endpoint. The trial, w…
    BioPharma Dive · 14d agoNegative readoutNegative↗ source
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  • Compliance worries keep AI adoption in drug manufacturing low, survey finds
    A new survey of more than 400 research and manufacturing professionals shows that over 90% of drugmakers have not committed to expanding AI use in regulated drug production. While AI is widely em…
    BioSpace · 14d agoRegulatoryNegative↗ source
  • BioSpace honors 40 emerging leaders shaping biopharma with breakthroughs in mRNA, gene and cell therapies
    BioSpace announced its latest 40 Under 40 cohort, recognizing young professionals who have made notable contributions across biopharma. The honorees span a range of roles, from scientific innovator…
    BioSpace · 14d agoPositive↗ source
  • Key Biopharma Conferences to Watch in 2027 Highlight Industry Trends
    The article lists major medical meetings slated for 2027 that serve as platforms for companies to present clinical data and network. Highlights include the J.P. Morgan Healthcare Conference in ear…
    BioPharma Dive · 14d agoNeutral↗ source
  • Season 2 of The Progress Profile podcast spotlights Alzheimer’s research and patient-centered trial design
    The Progress Profile: Alzheimer’s Research in Focus returns for a second season, offering conversations about Alzheimer’s disease and brain health. In the premiere episode, Dr. John Harrison, Dr.…
    BioPharma Dive · 14d agoNeutral↗ source
  • Shionogi makes $2B rare disease play with IntraBio buy
    With its acquisition of IntraBio, Shionogi will gain ownership over Aqneursa, which could hit peak global sales of $1 billion across its two indications in Niemann-Pick disease type C and ataxia-te…
    BioSpace · 14d ago↗ source
  • FDA extends review of Novo’s hemophilia A drug, citing manufacturing issues
    Despite the regulatory delay, Novo is still expecting a 2027 launch for its hemophilia A drug denecimig.
    BioSpace · 14d ago↗ source
  • Vaxcyte's next-gen pneumococcal vaccine matches leading shots in Phase 3 trial
    Vaxcyte reported that its experimental pneumococcal vaccine, VAX-31, achieved its primary efficacy goals in the first of three Phase 3 studies. In adults aged 50 and older, the vaccine performed o…
    BioPharma Dive · 15d agoPositive readoutPositive↗ source
  • Vaxcyte’s VAX-31 shows superior results in Phase 3, beating Pfizer and Merck’s pneumococcal vaccines and sparking $8 bn market hopes
    Vaxcyte reported that its investigational pneumococcal conjugate vaccine, VAX-31, met the co-primary endpoints in a Phase 3 trial, demonstrating non-inferiority to the existing shots from Pfizer an…
    BioSpace · 15d agoPositive readoutPositive↗ source
  • Genentech signs up to develop Alector’s preclinical blood-brain barrier therapy in $1.27 billion deal
    Genentech, a Roche subsidiary, announced a deal with Alector to obtain exclusive rights to its preclinical blood-brain barrier delivery asset, AL050. The agreement provides $100 million upfront an…
    BioSpace · 15d agoDealPositive↗ source
  • Nobel Prize honors optogenetics pioneers; Roche licenses Alector’s Parkinson’s enzyme therapy
    The Nobel Committee awarded this year’s Physiology or Medicine prize to three scientists whose work created the field of optogenetics. Their discoveries of a light‑sensing protein in algae and its…
    BioPharma Dive · 15d agoDealPositive↗ source
  • FDA urged to boost US access to new and experimental drugs as trials shift to China
    The piece highlights that the FDA has taken steps such as launching Operation TrialBlazer and tightening review of foreign clinical data, but argues that further action is required to keep the Unit…
    BioSpace · 15d agoRegulatoryNegative↗ source
  • Shionogi to acquire Texas-based IntraBio for $2 billion, adding marketed rare-disease drug Aqneursa
    Shionogi announced Monday it will buy IntraBio, a Texas biotech, for $2 billion in cash, making IntraBio a wholly owned subsidiary of its U.S. division. The deal gives Shionogi ownership of Aqneur…
    BioPharma Dive · 15d agoDealPositive↗ source
  • Lilly adds $870M to Gate Bioscience partnership to pursue new drug targets
    Eli Lilly is expanding its collaboration with Gate Bioscience, adding a new financial commitment of more than $870 million. The original July 2025 agreement gave Lilly access to Gate’s "Molecular…
    BioSpace · 15d agoDealPositive↗ source
  • AI drives faster drug development and reshapes biopharma manufacturing facilities
    AI is speeding up the identification of drug candidates, turning years of laboratory work into months by analyzing large biological datasets and accelerating early‑stage development. This accelera…
    BioPharma Dive · 15d agoPositive↗ source
  • Viking Therapeutics jumps 24% after Phase 1 obesity data, Longeveron falls 64% on mid-stage setback
    In September biotech stocks showed wide swings, with Viking Therapeutics gaining 24% and Longeveron dropping 64% as investors reacted to clinical data and trial setbacks. Viking reported Phase 1 r…
    BioSpace · 15d agoPositive readoutNeutral↗ source
  • Biogen's litifilimab shows clear or almost clear skin in cutaneous lupus after one year
    Biogen reported that its experimental antibody litifilimab produced clear or almost clear skin in patients with cutaneous lupus erythematosus after one year of treatment in a mid‑stage study. The r…
    BioSpace · 15d agoPositive readoutPositive↗ source
  • Kyverna Therapeutics reports encouraging data for first CAR-T therapy targeting autoimmune disease
    Kyverna Therapeutics released new data that strengthens its case for bringing the first CAR‑T treatment for an autoimmune condition to market. The results come after recent safety setbacks in simil…
    BioSpace · 15d agoPositive readoutNeutral↗ source
  • Roivant Sciences launches first solo drug, Lisraya, after FDA approval for dermatomyositis
    Roivant Sciences, which operates a hub-and-spoke subsidiary model, is stepping into the commercial arena with its inaugural solo product launch. The FDA has granted approval to the oral TYK2/JAK i…
    BioSpace · 15d agoApprovalPositive↗ source
  • CSL strikes up to $1.6B deal with Alentis for autoimmune drug with broad potential
    CSL will co-develop and co-promote Alentis Therapeutics' anti-claudin-1 therapy lixudebart for kidney and liver conditions, including primary sclerosing cholangitis and a systemic autoimmune diseas…
    BioSpace · 15d agoDealNeutral↗ source
  • Diagnostic-driven therapies face patient loss due to workflow gaps, new commercialization model proposed
    The sponsored article from Diaceutics highlights that while diagnostic-driven therapies are being developed faster than ever, many patients who could benefit never receive them. The authors attribu…
    BioPharma Dive · 15d agoNeutral↗ source
  • Swiss CDMOs and CROs experience rapid growth as global sponsors seek specialized manufacturing and decentralized trials
    Switzerland’s contract development and manufacturing organisations (CDMOs) and contract research organisations (CROs) are entering a new boom cycle, driven by rising global demand for specialised m…
    BioSpace · 15d agoDealPositive↗ source
  • FDA issues request for information on early-phase ibogaine trial design
    The FDA announced a request for information (RFI) to gather input on how to design early-phase clinical trials of ibogaine drug products. The agency is looking for comments on protocol elements su…
    fda press · 15d agoRegulatoryNeutral↗ source
  • Two Massachusetts biotech firms shut down, ending cancer and eye‑disease programs
    Adecto Pharmaceuticals, a Boston‑based biotech developing a treatment for cancers resistant to standard immunotherapy, announced it has ceased operations as of September 30. CEO Nora Minerva shared…
    BioSpace · 15d agoNegative↗ source